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Lifestyle Intervention for Heart Failure

N/A
Waitlist Available
Led By Karen Basen-Engquist, PhD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Previous chemotherapy that contributed to the development of heart failure
Must not have
Remain in NYHA class IV heart failure despite therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether cancer survivors who receive education and training about exercise are more likely to change their lifestyle and improve symptoms of heart failure.

Who is the study for?
This trial is for cancer survivors over 18 living in or near Houston, who've finished treatment or are on maintenance chemo. They must have heart failure (NYHA I-III) possibly due to previous chemotherapy and be mentally oriented. Those with severe heart failure (NYHA IV), conditions making exercise unsafe, or unable to consent are excluded.
What is being tested?
The study examines if lifestyle changes through education about exercise and dietary counseling can improve the lives of those with heart failure post-cancer treatment. Participants will receive either regular care or added training and advice on how to incorporate healthy habits.
What are the potential side effects?
Since this trial involves exercise and diet modification rather than medication, side effects may include muscle soreness, fatigue from increased activity levels, potential dietary adjustment issues like changes in bowel habits but generally low risk of serious side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
My heart failure was caused by previous chemotherapy.
Select...
I have heart failure with symptoms or test results confirming it.
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I have finished my cancer treatment or am only on long-term maintenance chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My heart failure is severe, even with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 3 trial • 300 Patients • NCT02008565
51%
Constipation
9%
Urinary tract infection
6%
Diarrhoea
6%
Headache
5%
Fall
5%
Abdominal distension
5%
Abdominal pain
5%
Upper respiratory tract infection
3%
Nausea
2%
Haemorrhoids
1%
Breast cancer
1%
Hip fracture
1%
Syncope
1%
Medical device removal
1%
Back pain
1%
Animal bite
1%
Suture related complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Education Only
Loperamide - Exercise Plus Biofeedback
Loperamide - Education Only
Placebo - Exercise Plus Biofeedback

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment3 Interventions
Exercise Training + Dietary Counseling
Group II: Group 1Experimental Treatment1 Intervention
Usual Care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Counseling
2011
Completed Phase 3
~2050
Exercise Training
2011
Completed Phase 3
~1470

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,160 Total Patients Enrolled
7 Trials studying Heart Failure
332 Patients Enrolled for Heart Failure
Karen Basen-Engquist, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
2,526 Total Patients Enrolled

Media Library

Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT00633633 — N/A
Heart Failure Research Study Groups: Group 1, Group 2
Heart Failure Clinical Trial 2023: Usual Care Highlights & Side Effects. Trial Name: NCT00633633 — N/A
Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT00633633 — N/A
~7 spots leftby May 2026
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